(a) Field of the Invention
The present invention relates to a method for producing a psyllium hydrophilic mucilloid with improved dispersibility and mixability and the novel composition thereby produced. In its method aspect, it relates to a novel process comprising dissolving a hydrolyzed starch oligosaccharide, a mono- or di-saccharide, a polyglucose, or a polymaltose in a suitable solvent system and applying the system as a thin film on the mucilloid and then drying. Optionally, where appropriate, the solution contains a low-calorie sweetener and/or a flavoring agent. In its composition aspect, the invention relates to a novel composition comprising psyllium hydrophillic mucilloid coated with a thin film of a hydrolyzed starch oligosaccharide, a mono- or di-saccharide, a polyglucose, or a polymaltose.
Psyllium hydrophilic mucilloid consists of the mucillaginous portion (the husk either milled or unmilled) of blond psyllium seeds. Psyllium hydrophilic mucilloid contains natural mucillage and forms a gelatinous mass on contact with water. It is useful in the treatment of constipation by acting as a fecal softener and also as a demulcent in the presence of inflamed mucosa. Psyllium hydrophilic mucilloid, however, exhibits poor dispersability and mixability in water. The numerous individual particles tend to agglomerate when psyllium hydrophilic mucilloid is mixed with water. Hydration takes place over the surface of such agglomerated aggregates to form gel-coated lumps, the interiors of which are still substantially dry, and these lumps are extremely difficult to disperse. This effect is aggravated by the fact that psyllium has a tendency to float on the surface of the water, allowing partially dissolved particles to agglomerate into large masses. In addition, the taste of psyllium hydrophilic mucilloid is unacceptable to many persons.
One attempt at alleviating the problems has been to dry mix the psyllium hydrophilic mucilloid with a high percentage of a sugar (typically about 50%). The taste is improved slightly and dispersibility and mixability are moderately improved by the addition of a sugar. However, diabetics and people who are on restricted diets may have difficulty taking sugar-treated psyllium hydrophilic mucilloid due to the high sugar content (3.5 g-7.0 g about 14 to 28 calories per dose). In addition, the cost of raw materials, storage and processing is higher with the sugar added.
(b) Prior Art
Psyllium hydrophilic mucilloid in combination with a high concentration of a sugar is widely known and available commercially for use in treating constipation. See e.g. Goodman and Gilman, The Pharmacological Basis of Therapeutics 4th Ed. pg 1026 (1970). Also in U.S. Pat. No. 3,455,714, a method is described for improving the dispersibility and dissolution rate in water of water soluble gums using cellulose derivatives. U.S. Pat. No. 4,321,263 relates to increasing the dispersibility of psyllium hydrophilic mucilloid by wetting the psyllium particles with an alcoholic solution of polyethylene glycol and/or polyvinylpyrrolidone.